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Metformin impurity amount, theoretically 1/90 of Ranitidine

By Kim, Jin-Gu | translator Choi HeeYoung

19.12.10 06:20:46

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MFDS "Total calculated '1/90' level of Ranitidine as a result of toxicity calculation. Cause of creation requires overhaul , Overhaul required

Agilent reports show similar results, 'Ranithidine 90%, Nizatidine 5%, Metformin 1% or less'

 ¡ãMolecular structure of Metformin

With Metformin, issues of impurity detection have been raised, and it is possible that N-nitrosodimethylamine (NDMA) will be detected much less than earlier Ranitidine or Nizatidine.

According to officials at the MFDS on Dec 9, a qualitative structure activity relationship (QSAR) is used as a simple test to determine the toxicity of a substance.

It is a test method that compares and predicts physical and chemical properties by similarity of intrinsic chemical structure. Since the properties of a substance are closely related to its molecular structure, it is a principle that similar physical structures have similar physical properties and toxicity.

In fact, the results of

Kim, Jin-Gu(kjg@dailypharm.com)
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